IT Compliance Lead Sap - Braine-l'Alleud, België - UCB S.A.

UCB S.A.
UCB S.A.
Geverifieerd bedrijf
Braine-l'Alleud, België

1 week geleden

Sophie Dubois

Geplaatst door:

Sophie Dubois

beBee Recruiter
Beschrijving

Make your mark for patients


We are looking for an
IT Compliance Lead, SAP ecosystem (GMP/GDP and non-GxP modules) who is quality driven, has an enthusiastic mindset and natural strong communication skills, to join us in our IT Compliance team, based in our Braine L'Alleud office, Belgium.


About the role


As an IT Compliance Lead, you will be in charge of the Validation and Compliance activities for the systems within your scope: SAP system and its ecosystem, related to GMP, GDP and non-GxP domains.

It includes leading the validation strategy for computerized system within this scope as well as maintaining and monitoring compliance level across the IT departments.

You will also define and review IT Processes for your IT scope, for compliance with policies and procedures.


Team


You will work within a team of highly skilled IT Compliance leads, and with a team of Validation SME assigned to your projects.

You will collaborate closely with the IT System Owners of the various SAP domains
as well as with many stakeholders within and outside of IT, mainly Process Owner, Quality Assurance, and IT Management.


What you'll do

  • Lead and manage the projects and validation activities from a budget, planning & resource point of view for the scope SAP system and its ecosystem.
  • Establish and communicate the rules, compliance standards, guidelines for sustainable Compliance & Quality across the managed scope.
  • Drive or contribute to tactical IT process improvement initiatives that are strategically aligned to the goal of the organization (e.g. process definition and improvements, skills improvements, etc.).
  • Ensure that systems are audit ready; Present and defend the systems during internal or external audits / inspections.
  • Provide support in addressing noncompliance situations and ensures that such cases are documented, investigated, resolved and/or mitigated (e


g:
CAPA management, training compliance, etc.).

  • Establish baselines of performance for quality; Define, implement, and perform quality reviews; Reports compliance status to management on a regular basis using agreed KPIs.
  • Responsible for all regulated activities and responsible to maintain the roadmap for a sustainable IT Compliance.

Interested? For this role we're looking for the following
education, experience
and
skills

  • Experience in Computer Systems Validation within a regulated environment with good knowledge of the GAMP
  • Good understanding of ERP and SAP systems: Understanding of SAP development approach is a must; Knowledge of at least one GxP SAP functional domain among the followin


g:
PP-PI, WM, QM, PM; Knowledge of SAP authorization and SAP Basis architecture

  • Good knowledge of GMP and GDP regulation, specifically related to Validation of Computerized Systems, Electronic Records & Electronic Signature (21 CFR Part 11 and Annex 11), Data Integrity and Pharmaceutical standards and their interpretation
  • Experience of +5 years in CSV domain in the Life Sciences (Pharmaceutical, Medical Devices) and Healthcare industries
  • Knowledge of system development lifecycle (SDLC) processes
  • Experience with computerized testing processes and testing tools (e.g., ALM from Micro Focus/Open Text)
  • Knowledge of the supporting processes: Change, Incident, Deviation, Periodic Review processes
  • Experience in dealing with Regulators and Auditors, preparation and/or inspection and audit defense
  • Knowledge of SAP S4/Hana, Experience with SAP functional domain, Agile methodology and validation
  • Fluent in English (spoken and written).
Are you ready to 'go beyond' to create value and make your mark for patients? If this sounds like you, then we would love to hear from you


About us
UCB is a global biopharmaceutical company, focusing on neurology and immunology. We are around 8,500 people in all four corners of the globe, inspired by patients and driven by science.


Why work for us?
At UCB, we don't just complete tasks, we create value. We aren't afraid to push forward, collaborate, and innovate to make our mark for patients.

We have a caring, supportive culture where everyone feels included, respected and has equitable opportunities to do their best work.

We 'go beyond' to create value for our patients, and always with a human focus, whether that's on our patients, our employees or our planet.

Working for us, you will discover a place where you can grow, and have the freedom to carve your own career path to achieve your full potential.


Learn more about sustainability at UCB and how it is integrated into our business approach.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/colour/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.
Meer banen van UCB S.A.
Bekijk alle vacatures van UCB S.A.